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Fosetyl-Al - Tolerances Established (undated)


     Tolerances were established for residues of aluminum tris
(Oethylphosphonate) of 0.5 p.p.m. in dry bulb onions; 55 p.p.m. in or on
Brassica (cole) leafy vegetables group; and 80 p.p.m. in or on leafy
vegetables (except Brassica vegetables) group.  The fungicide is known as
fosetyl-Al (Aliette).

     The new tolerances resulted from three petitions filed by Rhone-Poulenc.

     EPA said it has 'concluded that the available data provide limited
evidence for the carcinogenicity of fosetyl-Al in male rats and has classified
the pesticide as a Category C carcinogen (possible human carcinogen with
limited evidence of carcinogenicity in animals)....'  The agency concluded,
'Since the increase in the bladder tumor incidence was limited only to male
rats at doses well above the limit dose (1,000 mg/kg body weight/day for
carcinogenicity studies), EPA believes that no significant cancer risk would
be posed to humans.'

     Stating that a quantitative risk assessment is not appropriate, the
agency said:

     '(1)  The carcinogenic response observed with this chemical was confined
           solely to the high-dose males at one site (urinary bladder in
           rats); the recent data of a 90-day feeding study of fosetyl-Al in
           rats also showed a strong association between the presence of
           uroliths in the urinary bladder and the incidence of urinary
           bladder hyperplasia in treated rats;

     (2)  The tumor response was primarily due to an increase in benign

     (3)  The tumors were seen only in surviving animals at the time of
          terminal sacrifice;

     (4)  The carcinogenic effects were observed only at unusually high

     (5)  The chemical was not carcinogenic when administered in the diet to
          Charles River CD- 1 mice at dose levels ranging from 2,500 to
          30,000 ppm.  (357 to 4,286 mg/kg body weight/day); and

     (6)  Fosetyl-Al was not mutagenic in eight well-conducted genotoxic